Segmented transcatheter valve prosthesis having an unsupported valve segment

ABSTRACT

Embodiments hereof relate to a transcatheter valve prosthesis including a tubular fabric body, a first or inflow tubular scaffold attached to a first end portion of the tubular fabric body, and a second or outflow tubular scaffold attached to a second end portion of the tubular fabric body. A prosthetic valve component is disposed within and secured to an intermediate portion of the tubular fabric body that longitudinally extends between the first and second end portions of the tubular fabric body. The intermediate portion is unsupported such that neither of the first and second tubular scaffolds surrounds the intermediate portion of the tubular fabric body. The intermediate portion may include one or more windows for coronary access and may include one or more commissure reinforcement members coupled thereto to provide support for the prosthetic valve component.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/556,484, filed Dec. 1, 2014, now allowed, the disclosure of which isincorporated by reference herein in its entirety.

FIELD OF THE INVENTION

The invention relates in general to valve prostheses and moreparticularly to a valve prosthesis for transcatheter delivery.

BACKGROUND OF THE INVENTION

A human heart includes four heart valves that determine the pathway ofblood flow through the heart: the mitral valve, the tricuspid valve, theaortic valve, and the pulmonary valve. The mitral and tricuspid valvesare atrioventricular valves, which are between the atria and theventricles, while the aortic and pulmonary valves are semilunar valves,which are in the arteries leaving the heart. Ideally, native leaflets ofa heart valve move apart from each other when the valve is in an openposition, and meet or “coapt” when the valve is in a closed position.Problems that may develop with valves include stenosis, in which a valvedoes not open properly, and/or insufficiency or regurgitation in which avalve does not close properly. Stenosis and insufficiency may occurconcomitantly in the same valve. The effects of valvular dysfunctionvary, with regurgitation or backflow typically having relatively severephysiological consequences to the patient.

Recently, flexible prosthetic valves supported by stent or scaffoldstructures that can be delivered percutaneously using a catheter-baseddelivery system have been developed for heart and venous valvereplacement. These prosthetic valves may include either self-expandingor balloon-expandable stent structures with valve leaflets attached tothe interior of the stent structure. The prosthetic valve can be reducedin diameter, by compressing onto a balloon catheter or by beingcontained within a sheath component of a delivery catheter, and advancedthrough the venous or arterial vasculature. Once the prosthetic valve ispositioned at the treatment site, for instance within an incompetentnative valve, the stent structure may be expanded to hold the prostheticvalve firmly in place. One example of a stented prosthetic valve isdisclosed in U.S. Pat. No. 5,957,949 to Leonhardt et al. entitled“Percutaneous Placement Valve Stent”, which is incorporated by referenceherein in its entirety. Another example of a stented prosthetic valvefor a percutaneous pulmonary valve replacement procedure is described inU.S. Patent Application Publication No. 2003/0199971 A1 and U.S. Pat.No. 8,721,713, both filed by Tower et al., each of which is incorporatedby reference herein in its entirety.

Although transcatheter delivery methods have provided safer and lessinvasive methods for replacing a defective native heart valve,complications may arise including vessel trauma due to percutaneousdelivery within highly curved anatomy and/or due to a large deliveryprofile of the prosthesis, inaccurate placement of the valve prosthesis,conduction disturbances, coronary artery obstruction, and/or undesirableparavalvular leakage and/or regurgitation at the implantation site.Embodiments hereof are directed to a valve prosthesis having an improvedconfiguration to address one or more of the afore-mentionedcomplications.

BRIEF SUMMARY OF THE INVENTION

Embodiments hereof relate to a transcatheter valve prosthesis includinga tubular fabric body formed from a synthetic material, the tubularfabric body having opposing first and second end portions and anintermediate portion extending between the first and second endportions. A first tubular scaffold is attached to the tubular fabricbody along the first end portion thereof. A second tubular scaffold isattached to the tubular fabric body along the second end portionthereof. The first and second tubular scaffolds are independent fromeach other. A prosthetic valve component is disposed within and securedto the intermediate portion of the tubular fabric body. The intermediateportion of the tubular fabric body is unsupported such that neither ofthe first or second tubular scaffolds surround the intermediate portionof the tubular fabric body. The prosthesis has a compressedconfiguration for percutaneous delivery within a vasculature and anexpanded configuration for deployment within a native valve.

Embodiments hereof also relate to a transcatheter valve prosthesisincluding a tubular fabric body having a first end portion, a second endportion, and an intermediate portion that longitudinally extends betweenthe first and second end portions. A first tubular scaffold is attachedto the tubular fabric body along the first end portion thereof. A secondtubular scaffold is attached to the tubular fabric body along the secondend portion thereof. The first and second tubular scaffolds areconfigured to be self-expanding and are sized to deploy against nativevalve tissue. In addition, the first and second tubular scaffolds areindependent from each other. A prosthetic valve component is disposedwithin and secured to the intermediate portion of the tubular fabricbody. The prosthetic valve component includes three leaflets. Threereinforcement members are attached to the intermediate portion of thetubular fabric body, the three reinforcement members being aligned withcommissures of the three leaflets of the prosthetic valve component. Theintermediate portion of the tubular fabric body is unsupported such thatneither of the first or second tubular scaffolds surround theintermediate portion of the tubular fabric body and only the threereinforcement members are coupled to the intermediate portion. Theprosthesis has a compressed configuration for percutaneous deliverywithin a vasculature and an expanded configuration for deployment withina native valve.

Embodiments hereof also relate to a segmented transcatheter valveprosthesis including a tubular fabric body formed from a syntheticmaterial, a first tubular scaffold attached to the tubular fabric bodyalong a first end portion thereof such that the first tubular scaffoldand the first end portion form a first anchoring segment at an inflowend of the prosthesis, and a second tubular scaffold attached to thetubular fabric body along a second end portion thereof such that thesecond tubular scaffold and the second end portion form a secondanchoring segment at an outflow end of the prosthesis. The first andsecond tubular scaffolds are independent from each other. A prostheticvalve component is disposed within and secured to an intermediateportion of the tubular fabric body that extends between the first andsecond end portions of the tubular fabric body, the prosthetic valvecomponent and intermediate portion forming a central valve segment ofthe prosthesis. The central valve segment longitudinally extends betweenthe first and second anchoring segments of the prosthesis and isunsupported such that neither of the first or second tubular scaffoldssurround the intermediate portion of the tubular fabric body. Theprosthesis has a compressed configuration for percutaneous deliverywithin a vasculature and an expanded configuration for deployment withina native valve.

Embodiments hereof also relate to a method of implanting a transcathetervalve prosthesis within a native valve. The method includes the step ofpercutaneously advancing a catheter to a target site, wherein thecatheter includes a valve prosthesis in a compressed configurationmounted on a distal portion thereof. The prosthesis includes a tubularfabric body, a first tubular scaffold attached to a first end of thetubular fabric body, a second tubular scaffold attached to a secondopposing end of the tubular fabric body, and a prosthetic valvecomponent disposed within and secured to an intermediate portion of thetubular fabric body that longitudinally extends between the first andsecond tubular scaffolds. The first and second tubular scaffolds areconfigured to be self-expanding and are independent from each other. Theintermediate portion of the tubular fabric body is unsupported such thatneither of the first or second tubular scaffolds surrounds the tubularfabric body. An outer sheath of the catheter is retracted to expose thefirst tubular scaffold and the intermediate portion of the tubularfabric body, thereby deploying the first tubular scaffold. The catheteris proximally retracted in order to seat the first tubular scaffoldagainst native valve tissue at the target site. The catheter is furtherproximally retracted in order to tension the intermediate portion of thetubular fabric body. The outer sheath of the catheter is furtherretracted to expose the second tubular scaffold, thereby deploying andanchoring the second tubular scaffold against tissue at the target site.

BRIEF DESCRIPTION OF DRAWINGS

The foregoing and other features and advantages of the invention will beapparent from the following description of embodiments hereof asillustrated in the accompanying drawings. The accompanying drawings,which are incorporated herein and form a part of the specification,further serve to explain the principles of the invention and to enable aperson skilled in the pertinent art to make and use the invention. Thedrawings are not to scale.

FIG. 1 is a side view of a segmented transcatheter valve prosthesisaccording to an embodiment hereof, wherein the valve prosthesis is in anexpanded configuration.

FIG. 1A is a cross-sectional view taken along line A-A of FIG. 1.

FIG. 2 is an end view of the valve prosthesis of FIG. 1, taken from thesecond or outflow end of the prosthesis.

FIG. 3 is a perspective view of a first tubular scaffold of the valveprosthesis of FIG. 1, wherein the first tubular scaffold is removed fromthe valve prosthesis of FIG. 1 for illustrative purposes only and isshown in an expanded configuration.

FIG. 4 is a side view of a first tubular scaffold according to anotherembodiment hereof, wherein the first tubular scaffold has an alternativeflared end configuration and is shown in an expanded configuration.

FIG. 5 is a side view of a first tubular scaffold according to anotherembodiment hereof, wherein the first tubular scaffold has an alternativeflared end configuration and is shown in an expanded configuration.

FIG. 6 is a perspective view of a second tubular scaffold of the valveprosthesis of FIG. 1, wherein the second tubular scaffold is removedfrom the valve prosthesis of FIG. 1 for illustrative purposes only andis shown in an expanded configuration.

FIG. 7 is a side view of a second tubular scaffold according to anotherembodiment hereof, wherein the second tubular scaffold has a flared endconfiguration and is shown in an expanded configuration.

FIG. 8 is a side view of a second tubular scaffold according to anotherembodiment hereof, wherein the second tubular scaffold includes barbsand is shown in an expanded configuration.

FIG. 9 depicts a tubular fabric body according to another embodimenthereof, wherein the tubular fabric body is cut in an axial direction andlaid flat for illustrative purposes only and includes windows forcoronary access formed there-though.

FIG. 10 depicts a tubular fabric body according to another embodimenthereof, wherein the tubular fabric body is cut in an axial direction andlaid flat for illustrative purposes only and includes windows forcoronary access formed there-though as well as commissure reinforcementmembers that extend between the windows in order to aid in valvealignment and coaptation.

FIG. 11 is a perspective view of a valve prosthesis according to anotherembodiment hereof, wherein the valve prosthesis includes a first tubularscaffold having commissure reinforcement members that extend from thefirst tubular scaffold to aid in valve alignment and coaptation, whereinthe valve prosthesis is shown in an expanded configuration.

FIG. 12 is a side view of the first tubular scaffold of the valveprosthesis of FIG. 11, wherein the first tubular scaffold is removedfrom the valve prosthesis of FIG. 11 for illustrative purposes only andis shown in an expanded configuration.

FIG. 13 depicts a tubular fabric body according to another embodimenthereof, wherein the tubular fabric body is laid flat for illustrativepurposes only and includes windows for coronary access formedthere-though as well as commissure reinforcement members formed fromfabric that around the windows in order to aid in valve alignment andcoaptation.

FIG. 14 depicts a step of a method for implanting the valve prosthesisof FIG. 1, wherein a catheter including the valve prosthesis is advancedto a native aortic valve treatment site.

FIG. 15 depicts another step of a method for implanting the valveprosthesis of FIG. 1, wherein an outer sheath of the catheter isretracted to release the first tubular scaffold and intermediate portionof the valve prosthesis.

FIG. 16 depicts another step of a method for implanting the valveprosthesis of FIG. 1, wherein the catheter is proximally retracted toseat the first tubular scaffold of the valve prosthesis against thenative aortic valve annulus.

FIG. 17 depicts another step of a method for implanting the valveprosthesis of FIG. 1, wherein the catheter is proximally retracted tostretch or pull taut the intermediate portion of the valve prosthesis.

FIG. 18 depicts another step of a method for implanting the valveprosthesis of FIG. 1, wherein an outer sheath of the catheter has beenretracted to release the second tubular scaffold and the catheter hasbeen removed, leaving the deployed valve prosthesis implanted at thetreatment site.

FIG. 19 depicts a first tubular scaffold according to another embodimenthereof, wherein the first tubular scaffold includes a skirt and is shownin an expanded configuration.

DETAILED DESCRIPTION OF THE INVENTION

Specific embodiments of the present invention are now described withreference to the figures, wherein like reference numbers indicateidentical or functionally similar elements. Unless otherwise indicated,the terms “distal” and “proximal” are used in the following descriptionwith respect to a position or direction relative to the treatingclinician. “Distal” and “distally” are positions distant from or in adirection away from the clinician, and “proximal” and “proximally” arepositions near or in a direction toward the clinician. In addition, theterm “self-expanding” is used in the following description withreference to one or more support structures of the prostheses hereof andis intended to convey that the structures are shaped or formed from amaterial that can be provided with a mechanical memory to return thestructure from a compressed or constricted delivery configuration to anexpanded deployed configuration. Non-exhaustive exemplary self-expandingmaterials include a pseudo-elastic metal such as a nickel titanium alloyor nitinol, a spring-tempered steel, various polymers, or a so-calledsuper alloy, which may have a base metal of nickel, cobalt, chromium, orother metal. Mechanical memory may be imparted to a wire or scaffoldstructure by thermal treatment to achieve a spring temper in stainlesssteel, for example, or to set a shape memory in a susceptible metalalloy, such as nitinol. Various polymers that can be made to have shapememory characteristics may also be suitable for use in embodimentshereof to include polymers such as polynorborene, trans-polyisoprene,styrene-butadiene, and polyurethane. As well poly L-D lactic copolymer,oligo caprylactone copolymer and polycyclooctene can be used separatelyor in conjunction with other shape memory polymers.

The following detailed description is merely exemplary in nature and isnot intended to limit the invention or the application and uses of theinvention. Although the description of the invention is in the contextof replacement of aortic valves, the prosthetic valves of the inventioncan also be used in other areas of the body, such as for replacement ofa native mitral valve, for replacement of a native pulmonic valve, forreplacement of a native tricuspid valve, for use as a venous valve, orfor replacement of a failed previously-implanted prosthesis.Furthermore, there is no intention to be bound by any expressed orimplied theory presented in the preceding technical field, background,brief summary or the following detailed description.

Embodiments hereof relate to a transcatheter valve prosthesis that hasdistinct longitudinally-extending segments including two anchoringsegments at inflow and outflow ends of the prosthesis that are separatedand connected by a central valve segment that extends therebetween. Thetranscatheter valve prosthesis includes a tubular fabric body and firstand second scaffold or stent-like structures that are independent ofeach other, wherein each of the anchoring segments is comprised of oneof the first and second scaffolds and a first or second end portion ofthe tubular fabric body and wherein the central valve segment is anunsupported intermediate portion of the tubular fabric body that extendsbetween the anchoring segments and that houses a prosthetic valvecomponent therein.

More particularly, with reference to FIG. 1, embodiments hereof relateto a transcatheter valve prosthesis 100 is comprised of threelongitudinally-extending segments including a first anchoring segment108, a second anchoring segment 118, and a central valve segment 112that extends between first and second anchoring segments 108, 118. Whenconfigured as a replacement for an aortic valve, first anchoring segment108 functions as an inflow end of valve prosthesis 100 and extends intoand anchors within the aortic annulus of a patient's left ventricle,while second anchoring segment 118 functions as an outflow end of valveprosthesis 100 and is positioned in the patient's ascending aorta.“Inflow” and “outflow” refers to the direction of blood flow relative tothe valve prosthesis once it is implanted in a patient. The length ofeach segment, i.e., first anchoring segment 108, central valve segment112, and a second anchoring segment 118, may vary depending on thedesired application, on the desired native valve location for theprosthesis, and/or on the size of the patient. In an embodiment hereof,when valve prosthesis 100 is in the expanded configuration, each segmentis approximately a respective third of a total length of the prosthesis.

Transcatheter valve prosthesis 100 includes a tubular fabric body 102formed from a synthetic material, the tubular fabric body having a firstend 101 and a second or opposing end 103. Tubular fabric body 102includes a first end portion 102A, a second end portion 102C, and anintermediate portion 102B that extends between first and second endportions 102A, 102C. Tubular fabric body 102 is a synthetic graftmaterial shaped as a tubular body that defines a lumen 104 there-throughas shown in the cross-sectional view of FIG. 1A. More particularly,tubular fabric body 102 is constructed from a suitable biocompatiblematerial such as a low-porosity fabric, such as polyester, DACRON®, orpolytetrafluoroethylene (PTFE). Tubular fabric body 102 is thin-walledso that valve prosthesis 100 may be compressed into a small diameter,yet is capable of acting as a strong, leak-resistant fluid conduit whenexpanded to a cylindrical tubular form. In one embodiment, tubularfabric body 102 may be a knit or woven polyester, such as a polyester orPTFE knit, which can be utilized when it is desired to provide a mediumfor tissue ingrowth and the ability for the fabric to stretch to conformto a curved surface. Polyester velour fabrics may alternatively be used,such as when it is desired to provide a medium for tissue ingrowth onone side and a smooth surface on the other side. These and otherappropriate cardiovascular fabrics are commercially available from BardPeripheral Vascular, Inc. of Tempe, Ariz., for example.

Transcatheter valve prosthesis 100 also includes first and secondscaffold or stent-like structures 110, 120, respectively, that areindependent of each other. “Independent” as used herein means that firstand second tubular scaffolds are separate from each other and are notdirectly attached to each other. However, first and second tubularscaffolds 110, 120 are connected or indirectly linked to each other viacentral valve segment 112 that extends therebetween. First or inflowtubular scaffold 110 is attached to tubular fabric body 102 along firstend portion 102A such that first tubular scaffold 110 and first endportion 102A form first anchoring segment 108 of prosthesis 100.Similarly, second or outflow tubular scaffold 120 is attached to tubularfabric body 102 along second end portion 102C such that second tubularscaffold 120 and second end portion 102C form second anchoring segment118 of prosthesis 100. A prosthetic valve component 114 is disposedwithin and secured to intermediate portion 102B of tubular fabric body102 such that prosthetic valve component 114 and intermediate portion102B form central valve segment 112 of prosthesis 100. Central valvesegment 112 of prosthesis 100 longitudinally extends between first andsecond anchoring segments 108, 118 and is unsupported or scaffold-freesuch that neither of first or second tubular scaffolds 110, 120 surroundintermediate portion 102B of tubular fabric body 102 as will bedescribed in more detail herein.

More particularly, first and second tubular scaffolds 110, 120 arecoupled to first and second end portions 102A, 102C, respectively, oftubular fabric body 102 in order to bias and/or anchor the first andsecond end portions of tubular fabric body 102 into apposition with aninterior wall of a body lumen (not shown). First and second end portions102A, 102C, respectively, of tubular fabric body 102 are thus supportedby first and second tubular scaffolds 110, 120. As used herein,“supported” means that the graft material of first and second endportions 102A, 102C of tubular fabric body 102 has radial support alongits length and circumference. In particular, first tubular scaffold 110surrounds and overlaps with first end portion 102A of tubular fabricbody 102 and second tubular scaffold 120 surrounds and overlaps withsecond end portion 102C of tubular fabric body. First and second tubularscaffolds 110, 120 may longitudinally extend up to or beyond first andsecond ends 101, 103, respectively, of tubular fabric body 102. FIG. 1illustrates an embodiment in which first tubular scaffold 110longitudinally extends up to first end 101 of tubular fabric body 102,while second tubular scaffold 120 longitudinally extends beyond secondend 103 of tubular fabric body 102. Alternatively, in another embodiment(now shown), first tubular scaffold 110 may longitudinally extend beyondfirst end 101 of tubular fabric body 102 and/or second tubular scaffold120 may longitudinally extend up to second end 103 of tubular fabricbody 102. First and second tubular scaffolds 110, 120 may be attached ormechanically coupled to first and second end portions 102A, 102C,respectively, of tubular fabric body 102 by various means, such as, forexample, by stitching or suturing onto either an inner surface 107 (seeFIG. 1A) or an outer surface 106 of tubular fabric body 102. FIG. 1illustrates an embodiment in which first tubular scaffold 110 is coupledto inner surface 107 of tubular fabric body 102, while second tubularscaffold 120 is coupled to outer surface 106 of tubular fabric body 102.Alternatively, in another embodiment (now shown), first tubular scaffold110 is coupled to outer surface 106 of tubular fabric body 102 and/orsecond tubular scaffold 120 is coupled to inner surface 107 of tubularfabric body 102.

Conversely, intermediate portion 102B of tubular fabric body 102 isscaffold-free and unsupported. “Unsupported” as used herein means thatthe graft material of intermediate portion 102B of tubular fabric body102 has no radial support along its length or circumference and is notsurrounded by any tubular or annular scaffold or stent-like structure.In particular, first and second tubular scaffolds 110, 120 do notsurround and do not overlap intermediate portion 102B of tubular fabricbody 102. As such, intermediate portion 102B is relatively flexiblepermitting delivery of the prosthesis in a highly curved anatomy andreducing stresses on valve prosthesis 100. Valve prosthesis 100 havingunsupported intermediate portion 102B is particularly advantageous fordelivery through a highly curved anatomy, such as the aortic arch. Whenvalve prosthesis 100 is collapsed or compressed for delivery thereof,the segmented configuration of valve prosthesis 100 allows easiertraversing through a highly curved anatomy since anchoring segments 108,118 (which include first and second tubular scaffolds 110, 120) arerelatively short and are separated from each other by central valvesegment 112 (which includes unsupported intermediate portion 102B oftubular fabric body 102).

As previously mentioned, prosthetic valve component 114 is disposedwithin and secured to intermediate portion 102B of tubular fabric body102. Since prosthetic valve component 114 is disposed within and securedto unsupported intermediate portion 102B which does not include anytubular or annular scaffolds coupled thereto, valve prosthesis 100 has alower delivery or collapsed profile than a conventional prosthesis inwhich the single scaffold extends from a proximal end to a distal end ofthe prosthesis because prosthetic valve component 114 is surrounded byonly graft material without further support structures, such as tubularscaffolds, that would add to the delivery profile. In an embodimenthereof, valve prosthesis 100 in a compressed configuration has a profilebetween 8 and 14 French, depending upon the type and thickness of thegraft material utilized, when disposed within a catheter forpercutaneous delivery thereof.

Prosthetic valve component 114 is capable of blocking flow in onedirection to regulate flow there-through via valve leaflets 116 that mayform a bicuspid or tricuspid replacement valve. FIG. 2 is an end view ofFIG. 1 taken from the second or outflow end of the prosthesis andillustrates an exemplary tricuspid valve having three leaflets 116,although a bicuspid leaflet configuration may alternatively be used inembodiments hereof. More particularly, if valve prosthesis 100 isconfigured for placement within a native valve having three leafletssuch as the aortic, tricuspid, or pulmonary valves, valve prosthesis 100includes three valve leaflets 116 although the valve prosthesis is notrequired to have the same number of leaflets as the native valve. Ifvalve prosthesis 100 is configured for placement within a native valvehaving two leaflets such as the mitral valve, valve prosthesis 100includes two or three valve leaflets 116. Valve leaflets 116 are suturedor otherwise securely and sealingly attached to the inner surface ofintermediate portion 102B of tubular fabric body 102. Referring to FIG.2, leaflets 116 are attached along their bases to inner surface 107 ofintermediate portion 102B of tubular fabric body 102, for example, usingsutures or a suitable biocompatible adhesive. Adjoining pairs ofleaflets are attached to one another at their lateral ends to formcommissures 122, with free edges 124 of the leaflets forming coaptationedges that meet in area of coaptation 126.

Leaflets 116 may be made of pericardial material; however, the leafletsmay instead be made of another material. Natural tissue for replacementvalve leaflets may be obtained from, for example, heart valves, aorticroots, aortic walls, aortic leaflets, pericardial tissue, such aspericardial patches, bypass grafts, blood vessels, intestinal submucosaltissue, umbilical tissue and the like from humans or animals. Syntheticmaterials suitable for use as leaflets 116 include DACRON® commerciallyavailable from Invista North America S.A.R.L. of Wilmington, Del., othercloth materials, nylon blends, and polymeric materials. One polymericmaterial from which the leaflets can be made is an ultra-high molecularweight polyethylene material commercially available under the tradedesignation DYNEEMA from Royal DSM of the Netherlands. With certainleaflet materials, it may be desirable to coat one or both sides of theleaflet with a material that will prevent or minimize overgrowth. It isfurther desirable that the leaflet material is durable and not subjectto stretching, deforming, or fatigue.

First and second tubular scaffolds 110, 120 are shown removed from valveprosthesis 100 for illustrative purposes only in FIG. 3 and FIG. 6,respectively. First and second tubular scaffolds 110, 120 are bothself-expanding components that return to an expanded deployed state froma compressed or constricted delivery state. First and second tubularscaffolds 110, 120 are both sized to anchor valve prosthesis 100 againstnative valve tissue when the prosthesis is in the expandedconfiguration. In this embodiment, first and second tubular scaffolds110, 120 are tubular components having diamond-shaped openings 128A,128B, respectively, which may be formed by a laser-cut manufacturingmethod and/or another conventional stent/scaffold forming method aswould be understood by one of ordinary skill in the art. However, itwill be understood by one of ordinary skill in the art that theillustrated configurations of first and second tubular scaffolds 110,120 are exemplary and first and second tubular scaffolds 110, 120 mayhave alternative patterns or configurations. For example, in anotherembodiment (not shown), first and second tubular scaffolds 110, 120 mayinclude one or more sinusoidal patterned rings coupled to each other toform a tubular component. In another embodiment hereof (not shown), thefirst and second tubular scaffolds are configured to beballoon-expandable rather than self-expanding and thus would not berequired to be formed from a shape memory material.

First and second tubular scaffolds 110, 120 may each have distinctconfigurations and/or include an additional element that aids in fixingor anchoring valve prosthesis 100 within native valve anatomy. Moreparticularly, with reference to FIG. 3, first tubular scaffold 110 issized to extend into and anchor valve prosthesis 100 within the aorticannulus of a patient's left ventricle when valve prosthesis 100 isconfigured as a replacement for an aortic valve. As such, first tubularscaffold 110 includes a bulged or flared end 130 that is configured toseat valve prosthesis 100 within the aortic annulus, as described belowwith reference to FIGS. 14-18. The seating against the aortic annulusprovides anatomical alignment by positioning and aligning valveprosthesis 100 at the proper depth and eliminating canting of theprosthesis, which is unintentional slanting or tilting of theprosthesis. As shown in FIG. 3, flared end 130 has a diameter D₂ whichis larger than a diameter D₁ of an opposing end 131 of first tubularscaffold 110. The sizes of diameters D₁ and D₂ may vary according to aparticular patient's anatomy and/or the intended native valve forreplacement. In the embodiment of FIG. 3, flared end 130 longitudinallyextends a relatively short distance compared to the entire length offirst tubular scaffold 110. However, it will be understood by one ofordinary skill in the art that the illustrated configuration of flaredend 130 is exemplary and the flared end of first tubular scaffolds 110may have alternative patterns or configurations. For example, FIG. 4 andFIG. 5 illustrate alternative configurations of a flared end. A firsttubular scaffold 410 of FIG. 4 includes a flared portion 430 whichgradually tapers toward opposing end 431 and extends the entire lengthof the tubular scaffold. In addition, a first tubular scaffold 510 ofFIG. 5 includes a flared end 530 which tapers and extends approximatelyhalf the length of the tubular scaffold. Further, the flared ends mayhave a generally curved outer surface or profile similar to the flaredend configuration shown in FIG. 7.

With reference to FIG. 6, second tubular scaffold 120 is sized to extendinto and anchor valve prosthesis 100 within the patient's ascendingaorta when valve prosthesis 100 is configured as a replacement for anaortic valve. Second tubular scaffold 120 has a generally straightprofile such that the opposing ends thereof each have a diameter D₃ asshown in FIG. 6. The size of diameter D₃ may vary according to aparticular patient's anatomy. In another embodiment hereof, shown inFIG. 7, a second tubular scaffold 720 may include a bulged or flared end730 to aid in fixation thereof to the aorta. Flared end 730 has adiameter D₄ which is larger than diameter D₃ of the opposing end ofsecond tubular scaffold 720. When coupled to a tubular fabric body suchas tubular fabric body 102 and used as an aortic valve prosthesis,second tubular scaffold 720 would be oriented such that flared end 730forms the outflow end of the prosthesis.

In another embodiment hereof, shown in FIG. 8, a second tubular scaffold820 may include a plurality of barbs 832 to aid in fixation thereof tothe aorta. Barbs 832 radially extend away from second tubular scaffold820, and each include a free end that is sharp enough to engage withtissue for implantation of the valve prosthesis. Barbs 832 extend at anacute angle relative to the outer surface of second tubular scaffold 820so that they extend at least slightly outward relative to the outersurface of the tubular scaffold. Barbs 832 may be coupled to secondtubular scaffold 820 or integrally formed therewith. When coupled to atubular fabric body such as tubular fabric body 102 and used as anaortic valve prosthesis, second tubular scaffold 820 would be orientedsuch that barbs 832 are positioned at the outflow end of the prosthesis.

In addition to and/or as an alternative to the scaffold configurationsor additional elements described above that aid in fixing or anchoringvalve prosthesis 100 within native valve anatomy, second or outflowtubular scaffold 120 may be configured to exert a higher radial forcethan first or inflow tubular scaffold 110. As used herein, “radialforce” includes both a radial force exerted during expansion/deploymentas well as a chronic radial force continuously exerted afterimplantation such that a scaffold has a predetermined compliance orresistance as the surrounding native anatomy, i.e., the ascending aortaor the native valve annulus, expands and contracts during the cardiaccycle. First or inflow tubular scaffold 110 is configured to have alower radial force in order to reduce the likelihood of conductiondisturbances that may occur in the aortic annulus while second oroutflow tubular scaffold 120 is configured to have a higher radial forcein order to ensure that valve prosthesis 100 is anchored within thenative valve anatomy. In order to configure the tubular scaffolds withdiffering relative radial forces, second or outflow tubular scaffold 120may be constructed with relatively thicker and/or shorter segments ofmaterial that form diamond shaped openings 128B. Conversely, first orinflow tubular scaffold 110 may be constructed with relatively thinnerand/or longer segments of material that form diamond shaped openings128A. Shorter and/or thicker scaffold segments have less flexibility butgreater radial force to ensure that second or outflow tubular scaffold120 seals against the native anatomy. Other variations or modificationof the tubular scaffolds may be used to configure the tubular scaffoldswith differing relative radial forces without departing from the scopeof the present invention.

FIG. 9 illustrates another embodiment of a tubular fabric body 902 cutin an axial direction and laid flat for illustrative purposes only.Tubular fabric body 902 may include one or more windows or openings 934formed there-through along unsupported intermediate portion 902B thereofin order to allow access to one or more coronary arteries. Moreparticularly, in the aortic valve, the coronary arteries originate orbranch from two of the three native valve sinuses. The left coronaryartery originates from the left posterior aortic sinus, and the rightcoronary artery originates from the anterior aortic sinus. Usually, novessels branch from the right posterior aortic sinus, which is thereforeknown as the non-coronary sinus. When valve prosthesis 100 is configuredas a replacement for an aortic valve, windows 934 formed alongunsupported intermediate portion 902B of tubular fabric body 902increase perfusion and accessibility to the coronary arteries. Althoughtubular fabric body 902 is shown with three windows or openings 934 forpositioning within each native valve sinus, tubular fabric body 902 mayalternatively be provided with one or two openings. Windows 934 may beany shape, and advantageously may be of a relatively larger size thancoronary access windows or openings formed on a conventional prosthesisin which the single scaffold extends from a proximal end to a distal endof the prosthesis. More particularly, coronary access openings formed ona conventional prosthesis in which the single scaffold extends from aproximal end to a distal end of the prosthesis are limited in size dueto the scaffold or stent and the coronary access openings can be nolarger than the openings of the single scaffold or stent of theprosthesis. Conversely, unsupported intermediate portion 902B of tubularfabric body 902 need only include enough material to couple a prostheticvalve component thereto, and as such windows 934 are of a relativelyincreased size or dimension that may extend between adjacent leaflets ofthe prosthetic valve component.

FIG. 10 illustrates another embodiment of a tubular fabric body 1002 cutin an axial direction and laid flat for illustrative purposes only.Similar to tubular fabric body 902, tubular fabric body 1002 includesthree windows or openings 1034 formed there-through along unsupportedintermediate portion 1002B thereof in order to allow access to one ormore coronary arteries. In addition to windows 1034, tubular fabric body1002 includes three reinforcement members 1036 coupled to intermediateportion 1002B. Reinforcement members 1036 extend between windows 1034and are aligned with commissures of the three leaflets of the prostheticvalve component (not shown). Reinforcement members 1036 serve toreinforce the graft material of unsupported intermediate portion 1002Baround the commissures of the three leaflets of the prosthetic valvecomponent in order to aid in valve alignment and coaptation. In theembodiment of FIG. 10, reinforcement members 1036 are generally U-shapedbut it will be apparent to one of ordinary skill in the art thatreinforcement members 1036 may be other configurations, including alinear configuration, a V-shaped configuration, or other configurationsuitable for providing support to the three leaflets of the prostheticvalve component. FIG. 10 illustrates an embodiment in whichreinforcement members 1036 are coupled to the inner surface of thetubular fabric body 102. However, reinforcement members 1036 may beattached or mechanically coupled to tubular fabric body 1002 by variousmeans, such as, for example, by stitching or suturing onto either aninner surface or an outer surface of tubular fabric body 1002 or othermethods of attachment including gluing and/or heat treatments to embedreinforcement members 1036 into tubular fabric body 1002. Reinforcementmembers 1036 may be formed from a metallic or polymeric material that issufficiently rigid to provide support to the three leaflets of theprosthetic valve component such as but not limited to Nitinol,Cobalt-chromium, Platinum-Iridium, 316L Stainless Steel, Polyethylene,polyurethane, polypropolyne, or PEEK.

Reinforcement members 1036 are individual components or elements thatare attached to intermediate portion 1002B of tubular fabric body 1002but not attached to each other. As such, reinforcement members 1036 arenot configured to provide circumferential or radial support tounsupported intermediate portion 1002B of tubular fabric body 1002.Unlike first and second scaffolds (not shown in FIG. 10) that are to becoupled along first and second end portions 1002A, 1002C of tubularfabric body 1002, reinforcement members 1036 cannot be used as anchoringmechanisms because reinforcement members 1036 provide or exert no radialexpansion force. In an embodiment hereof, reinforcement members 1036 areonly attached to intermediate portion 1002B of tubular fabric body 1002and are not attached to any other structure of the valve prosthesis. Inanother embodiment hereof, the reinforcement members may be coupled toor extend from the first tubular scaffold of the valve prosthesis. Moreparticularly, FIGS. 11-12 illustrate an embodiment in which a valveprosthesis 1100 includes a first or inflow tubular scaffold 1110 havingreinforcement members 1136 extending therefrom. Reinforcement members1136 may be attached to first tubular scaffold 1110 or may be integrallyformed therewith via a laser-cut manufacturing method. First tubularscaffold 1110 includes a flared end 1130, which forms the inflow end ofthe prosthesis, and reinforcement members 1136 are attached to or formedon opposing end 1131 of first tubular scaffold 1110. Valve prosthesis1100 also includes a second or outflow tubular scaffold 1120. Similar tovalve prosthesis 100, valve prosthesis 1100 includes a first anchoringsegment 1108 that includes first tubular scaffold 1110 and first endportion 1102A of tubular fabric body 1102, a second anchoring segment1118 that includes second tubular scaffold 1120 and second end portion1102C of tubular fabric body 1102, and a central valve segment 1112 thatincludes intermediate portion 1102B of tubular fabric body and aprosthetic valve component (not shown in FIG. 11) that is disposedwithin and secured to intermediate portion 1102B of tubular fabric body1102. Intermediate portion 1102B is unsupported such that neither offirst or second tubular scaffolds 1110, 1120 surround the graft materialthereof and only three reinforcement members 1136 are coupled thereto.Intermediate portion 1102B also includes three windows 1134 for coronaryaccess.

FIG. 13 illustrates another embodiment of a tubular fabric body 1302laid flat out for illustrative purposes only. Similar to tubular fabricbody 902, tubular fabric body 1302 includes three windows or openings1334 formed there-through along unsupported intermediate portion 1302Bthereof in order to allow access to one or more coronary arteries. Inaddition to windows 1334, tubular fabric body 1302 includes threereinforcement members 1336 coupled to intermediate portion 1302B. Inthis embodiment, reinforcement members 1336 are formed by attachingadditional fabric material to at least a portion of the perimeters ofwindows 1334. In an embodiment, the additional fabric material mayinclude extra folded fabric. In another embodiment, the additionalfabric material may include a metallic or polymeric wire supportelement. Reinforcement members 1336 reinforce or strengthen thecommissure region of the valve by shaping the leaflets and supportingthe leaflets during opening and closing thereof, and thus provide morereliable leaflet coaptation. In addition to aiding in valve alignmentand coaptation, reinforcement members 1336 reinforce or strengthen theperimeter of windows 1334.

FIGS. 14-18 illustrate an exemplary method of implanting theabove-described transcatheter valve prosthesis 100 within a native valveaccording to an embodiment hereof. As will be understood by one ofordinary skill in the art, valve prosthesis 100 in a radially compressedconfiguration is loaded onto a distal portion of a catheter 1450. Theradially compressed configuration of valve prosthesis 100 is suitablefor percutaneous delivery within a vasculature. Catheter 1450 isconfigured for percutaneous transcatheter valve replacement, and may beone of, but is not limited to, the delivery systems described in U.S.Patent Publication No. 2011/0245917 to Savage et al., U.S. PatentPublication No. 2011/0251675 to Dwork, U.S. Patent Publication No.2011/0251681 to Shipley et al., U.S. Patent Publication No. 2011/0251682to Murray, III et al., and U.S. Patent Publication No. 2011/0264202 toMurray, III et al., each of which is herein incorporated by reference inits entirety. As shown in FIG. 14, in accordance with techniques knownin the field of interventional cardiology and/or interventionalradiology, catheter 1450 having distal end 1452 is transluminallyadvanced in a retrograde approach through the vasculature to thetreatment site, which in this instance is a target diseased nativeaortic valve AV that extends between a patient's left ventricle LV and apatient's aorta A. The coronary arteries C_(A) are also shown on thesectional view of FIG. 14. Delivery of catheter 1450 to the nativeaortic valve AV may be accomplished via a percutaneous transfemoralapproach or may be positioned within the desired area of the heart viadifferent delivery methods known in the art for accessing heart valves.During delivery, valve prosthesis 100 remains compressed within an outersheath 1454 of catheter 1450. Catheter 1450 is advanced until distal end1452 is distal to the native aortic valve AV and disposed within theleft ventricle LV as shown in FIG. 14. In an embodiment, catheter 1450is advanced approximately 5 mm into the left ventricle LV.

Once catheter 1450 is positioned as desired, outer sheath 1454 ofcatheter 1450 is retracted to expose first anchoring segment 108 (andthus first tubular scaffold 110) and at least a portion of central valvesegment 112 of prosthesis 100. Once released from outer sheath 1454,self-expanding first tubular scaffold 110 returns to its expanded ordeployed configuration as shown in FIG. 15. Upon release from outersheath 1454, intermediate portion 102B of fabric tubular body 102 whichhouses prosthetic valve component 114 may include slack 1555 in whichthe material thereof is baggy, saggy, or otherwise loose. Slack 1555 maybe present since intermediate portion 102B is not supported by anytubular or circumferential scaffold elements. Further, upon release fromouter sheath 1454, flared end 130 of first tubular scaffold 110 isslightly spaced apart from native aortic valve AV. At this point in theprocedure, second tubular scaffold 120 is still restrained within outersheath 1454.

Referring to FIG. 16, catheter 1450 is then proximally retracted asindicated by directional arrow 1656 in order to seat flared end 130 offirst tubular scaffold 110 against the annulus of the native aorticvalve AV. The entire catheter 1450 having valve prosthesis 100 mountedthereon may be pulled or proximally retracted by the user, or thecatheter may include a separate mechanism (not shown) such that valveprosthesis 100 may be separately or independently pulled or proximallyretracted without retracting the entire catheter 1450. With flared end130 of first tubular scaffold 110 seated in apposition with the annulusof native aortic valve AV, catheter 1450 is further proximally retractedas indicated by directional arrow 1758 in order to supply tension tointermediate portion 102B of tubular fabric body 102 as shown in FIG.17. Catheter 1450 is pulled proximally until intermediate portion 102Bof tubular fabric body 102 is taut or stretched to a generally straightconfiguration and no slack is present along the length of intermediateportion 102B.

After intermediate portion 102B of tubular fabric body 102 is taut,outer sheath 1454 of catheter 1450 is retracted to expose secondanchoring segment 118 (and thus second tubular scaffold 120). Oncereleased from outer sheath 1454, self-expanding second tubular scaffold120 returns to its expanded or deployed configuration. Second tubularscaffold 120 deploys against the aorta A, thereby anchoring valveprosthesis 100 to the aortic wall. Catheter 1450 is then removed andvalve prosthesis 100 remains deployed within the native aortic valve AVas shown in FIG. 18. After deployment, tension is present between firstand second tubular scaffolds and the tension is sufficient to maintainthe seal at the aortic annulus during the full cardiac cycle and alsoholds tubular fabric body 102 taut to maintain a generally straightconfiguration and proper valve function during the cardiac cycle. If thenative aortic valve AV includes native valve leaflets (not shown inFIGS. 14-18) and such leaflets have not been removed or excised, valveprosthesis 100 is deployed within the native valve leaflets of thepatient's defective valve, retaining the native valve leaflets in apermanently open state.

In any embodiment hereof, a skirt or other sealing material may becoupled to the first tubular scaffold. As previously described, whenconfigured as a replacement for an aortic valve, the first anchoringsegment of valve prosthesis functions as an inflow end of the valveprosthesis and extends into and anchors within the aortic annulus of apatient's left ventricle. The native valve annulus may include surfaceirregularities on the inner surface thereof, and as a result one or moregaps or cavities/crevices may be present or may form between theperimeter of the valve prosthesis and the native valve annulus. Forexample, calcium deposits may be present on the native valve leaflets(e.g., stenotic valve leaflets) and/or shape differences may be presentbetween the native heart annulus and the valve prosthesis. Moreparticularly, in some cases native annuli are not perfectly rounded andhave indentations corresponding to the commissural points of the nativevalve leaflets. As a result, a prosthesis having an approximatelycircular shape does not provide an exact fit in a native valve. Thesesurface irregularities, whatever their underlying cause, can make itdifficult for conventional prosthetic valves to form a blood tight sealbetween the prosthetic valve and the inner surface of the valve annulus,causing undesirable paravalvular leakage and/or regurgitation at theimplantation site. FIG. 19 illustrates a side view of a first tubularscaffold 1910 according to another embodiment hereof in which the firsttubular scaffold includes a skirt 1960. Skirt 1960 functions to occludeor fill gaps between the perimeter of a valve prosthesis and the nativevalve annulus, thereby reducing, minimizing, or eliminating leaksthere-through. Skirt 1960 extends around an outer or exterior surface offirst tubular scaffold 1910 to block blood flow around the outerperimeter of the valve prosthesis (not shown in FIG. 19), therebyminimizing and/or eliminating any paravalvular leakage at theimplantation site. In this embodiment, when assembled into atranscatheter valve prosthesis, first scaffold 1910 is coupled to anouter surface of a tubular fabric body (not shown in FIG. 19) such thatfirst scaffold 1910 is sandwiched between the tubular fabric body on theinner surface thereof and skirt 1960 on the outer surface thereof. Whendeployed, skirt 1960 may be positioned in situ at the native valveannulus, slightly above the valve annulus, slightly below the valveannulus, or some combination thereof. The length of skirt 1960 may varyaccording to application and skirt 1960 may be shorter or longer thanshown. For example, in another embodiment hereof, skirt 1960 extendsbeyond a proximal end of first scaffold 1910 such that, when assembledinto a transcatheter valve prosthesis, skirt 1960 overlays the tubularfabric body at the location of the prosthetic valve component. Suitablematerials for skirt 1960 include but are not limited to a low-porositywoven fabric, such as polyester, Dacron fabric, or PTFE. Porousmaterials advantageously provide a medium for tissue ingrowth, andbioabsorbable materials and/or polyurethane foam with low density andoptimal porosity promote sealing of the device to the anatomy. Further,skirt 1960 may be pericardial tissue or may be a knit or wovenpolyester, such as a polyester or PTFE knit, both of which provide amedium for tissue ingrowth and have the ability to stretch to conform toa curved surface. Polyester velour fabrics may alternatively be used,such as when it is desired to provide a medium for tissue ingrowth onone side and a smooth surface on the other side.

While various embodiments according to the present invention have beendescribed above, it should be understood that they have been presentedby way of illustration and example only, and not limitation. It will beapparent to persons skilled in the relevant art that various changes inform and detail can be made therein without departing from the spiritand scope of the invention. Thus, the breadth and scope of the presentinvention should not be limited by any of the above-described exemplaryembodiments, but should be defined only in accordance with the appendedclaims and their equivalents. It will also be understood that eachfeature of each embodiment discussed herein, and of each reference citedherein, can be used in combination with the features of any otherembodiment. All patents and publications discussed herein areincorporated by reference herein in their entirety.

What is claimed is:
 1. A transcatheter valve prosthesis, the prosthesiscomprising: a tubular fabric body formed from a synthetic material, thetubular fabric body having a first end portion, a second end portion andan intermediate portion extending between the first and second endportions, wherein the tubular fabric body defines a lumen there-through;a first tubular scaffold attached to the tubular fabric body along thefirst end portion thereof; a second tubular scaffold attached to thetubular fabric body along the second end portion thereof, wherein thefirst and second tubular scaffolds are independent from each other; aprosthetic valve component disposed within and secured to theintermediate portion of the tubular fabric body, the prosthetic valvecomponent being configured to block blood flow in one direction toregulate blood flow through the lumen of the tubular fabric body,wherein the prosthetic valve component includes at least two leafletsand at least two commissures, each commissure being formed by attachedadjacent lateral ends of an adjoining pair of the at least two leaflets;and at least two reinforcement members that are attached to theintermediate portion of the tubular fabric body, wherein each of the atleast two reinforcement members is aligned with a respective commissureof the at least two leaflets of the prosthetic valve component, and eachof the at least two reinforcement members is a U-shaped segment having afirst end adjacent to the first tubular scaffold, a second end adjacentto the first tubular scaffold, a first straight portion extending fromthe first end and longitudinally oriented along the respectivecommissure, a second straight portion extending from the second end andlongitudinally oriented along the respective commissure, and a curvedportion opposing the first and second ends and formed between the firstand second straight portions, wherein the intermediate portion of thetubular fabric body includes an unsupported portion that is notsurrounded by a tubular scaffold such that the unsupported portion ofthe intermediate portion of the tubular fabric body has no radialsupport along its length or circumference, and wherein at least twowindows are formed through the intermediate portion of the tubularfabric body, with the at least two windows being circumferentiallypositioned relative to the at least two commissures of the prostheticvalve component such that a window is disposed between adjacentcommissures, and wherein the prosthesis has a compressed configurationfor percutaneous delivery within a vasculature and an expandedconfiguration for deployment within a native valve.
 2. The prosthesis ofclaim 1, wherein the first and second tubular scaffolds havediamond-shaped openings that are laser-cut into the tubular scaffoldsand are configured to be self-expanding and are sized to anchor theprosthesis against native valve tissue when the prosthesis is in theexpanded configuration.
 3. The prosthesis of claim 1, wherein the secondtubular scaffold extends beyond the second end portion of the tubularfabric body.
 4. The prosthesis of claim 1, wherein the second tubularscaffold is configured to have a higher radial force than the firsttubular scaffold.
 5. The prosthesis of claim 1, wherein the secondtubular scaffold includes barbs on an outer surface thereof.
 6. Theprosthesis of claim 1, wherein the first tubular scaffold is flared suchthat a first end of the first tubular scaffold has a smaller diameterthan a second end of the first tubular scaffold.
 7. The prosthesis ofclaim 1, wherein the first tubular scaffold is coupled to an outersurface of the tubular fabric body and a skirt is coupled to an outersurface of the first tubular scaffold such that the first tubularscaffold is sandwiched between the tubular fabric body and the skirt. 8.The prosthesis of claim 1, wherein when the prosthesis is in theexpanded configuration each of the first tubular scaffold, theintermediate portion of the tubular fabric body and the second tubularscaffold comprises a respective third of a total length of theprosthesis.
 9. The prosthesis of claim 1, wherein the at least tworeinforcement members are not attached to the first tubular scaffold orthe second tubular scaffold.
 10. The prosthesis of claim 1, wherein theat least two reinforcement members extend from the first tubularscaffold.
 11. A transcatheter valve prosthesis for implantation within anative valve, the prosthesis comprising: a tubular fabric body having afirst end portion, a second end portion, and an intermediate portionthat longitudinally extends between the first and second end portions,wherein the tubular fabric body defines a lumen there-through; a firsttubular scaffold attached to the tubular fabric body along the first endportion thereof; a second tubular scaffold attached to the tubularfabric body along the second end portion thereof, wherein the first andsecond tubular scaffolds are configured to be self-expanding and aresized to deploy against native valve tissue, the first and secondtubular scaffolds being independent from each other; a prosthetic valvecomponent disposed within and secured to the intermediate portion of thetubular fabric body, the prosthetic valve component being configured toblock blood flow in one direction to regulate blood flow through thelumen of the tubular fabric body, wherein the prosthetic valve componentincludes three leaflets and three commissures, each commissure beingformed by attached adjacent lateral ends of an adjoining pair of thethree leaflets; and three reinforcement members that are attached to theintermediate portion of the tubular fabric body, wherein each of thethree reinforcement members is aligned with a respective commissure ofthe three leaflets of the prosthetic valve component and each of thethree reinforcement members is a U-shaped segment having a first endadjacent to the first tubular scaffold, a second end adjacent to thefirst tubular scaffold, a first straight portion extending from thefirst end and longitudinally oriented along the respective commissure, asecond straight portion extending from the second end and longitudinallyoriented along the respective commissure, and a curved portion opposingthe first and second ends and formed between the first and secondstraight portions, wherein the intermediate portion of the tubularfabric body includes an unsupported portion such that neither of thefirst or second tubular scaffolds surround the unsupported portion ofthe tubular fabric body, and wherein three windows are formed throughthe intermediate portion of the tubular fabric body, wherein the threewindows are circumferentially positioned relative to the threecommissures of the prosthetic valve component such that a window isdisposed between adjacent commissures, and wherein the prosthesis has acompressed configuration for percutaneous delivery within a vasculatureand an expanded configuration for deployment within a native valve. 12.The prosthesis of claim 11, wherein the three reinforcement members arenot attached to the first tubular scaffold or the second tubularscaffold.
 13. The prosthesis of claim 11, wherein the threereinforcement members extend from the first tubular scaffold.
 14. Theprosthesis of claim 11, wherein the second tubular scaffold isconfigured to have a higher radial force than the first tubularscaffold.